![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
Sponsors and Collaborators: |
SOFAR S.p.A. St. Orsola Hospital |
---|---|
Information provided by: | SOFAR S.p.A. |
ClinicalTrials.gov Identifier: | NCT00774007 |
Emerging evidence indicates the presence of low-grade mucosal inflammation and its pathogenetic role in IBS. The aim of this pilot study is to provide that mesalazine treatment of IBS patients reduces low grade colonic inflammation.
Condition | Intervention | Phase |
---|---|---|
Irritable Bowel Syndrome |
Drug: mesalazine Drug: placebo |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Effect of Mesalazine on Low Grade Mucosal Inflammation in Irritable Bowel Syndrome. A Pilot Double Blind Placebo Controlled Study. |
Enrollment: | 20 |
Study Start Date: | September 2004 |
Study Completion Date: | November 2005 |
Primary Completion Date: | November 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Placebo: Placebo Comparator
Placebo
|
Drug: placebo |
Mesalazine: Active Comparator
mesalazine 800 mg t.i.d.
|
Drug: mesalazine |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Italy | |
Department of Internal Medicine & Gastroenterology | |
Bologna, Italy, 40138 |
Principal Investigator: | Giovanni Barbara, MD | University of Bologna |
Study Chair: | Roberto Corinaldesi, MD | University of Bologna |
Responsible Party: | Department of Internal Medicine and Gastroenterology, University of Bologna, Bologna, ITALY ( Dr. Giovanni Barbara ) |
Study ID Numbers: | IBS-01/03 |
Study First Received: | October 15, 2008 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00774007 |
Health Authority: | Italy: National Institute of Health |
Irritable bowel syndrome, abdominal pain, abdominal bloating, immune cells, mast cells |
Digestive System Diseases Mucositis Mesalamine Gastrointestinal Diseases Abdominal Pain Colonic Diseases |
Irritable Bowel Syndrome Pain Intestinal Diseases Colonic Diseases, Functional Inflammation |
Anti-Inflammatory Agents Disease Physiological Effects of Drugs Pharmacologic Actions Pathologic Processes Analgesics, Non-Narcotic Sensory System Agents |
Syndrome Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |